What are the responsibilities and job description for the Regulatory Associate position at KVK Tech, Inc.?
Job Description
Department: Regulatory Affairs
Job Title: Regulatory Associate
Specialization (If any)
Bachelor’s Degree in Pharmacy, Chemistry or Scientific Discipline preferred
Experience Requirement
N/A
Number of Years
N/A
N/A
Licenses
N/A
Other
N/A
Department: Regulatory Affairs
Job Title: Regulatory Associate
- Role Purpose:
- Key Duties & Responsibilities:
- Interacts effectively with cross functional teams to coordinate/facilitate procurement of documentation required for regulatory submissions, ensuring that departmental timelines are met.
- Create documents in accordance with eCTD specifications.
- Prepare and submit regulatory submissions using eCTD software, publishing tool to FDA.
- Author, compile and review technical documents (CMC) for accuracy and acceptability in New Applications (i.e. ANDAs or NDAs], Amendments, Supplements, PADER, Annual Reports and other required FDA filings to ensure high-quality submissions and expeditious approvals from FDA.
- Coordinate preparation of SPL for drug products and update labelling, annual drug listing.
- Reviews and signs-off on change control documentation. Assesses changes and their impact on the business based on an understanding of product, regulatory guidelines and applicable federal laws.
- Update and maintain the internal database as needed.
- Comply with FDA guidelines/Company Policies of Data Integrity.
- Effectively prioritizes competing tasks in a fast-paced and dynamic environment.
- Other duties as required or delegated
- Typical Supervisory Responsibility:
- Education & Experience:
Specialization (If any)
Bachelor’s Degree in Pharmacy, Chemistry or Scientific Discipline preferred
Experience Requirement
N/A
Number of Years
N/A
- Technical competencies/ Certifications/ Licenses:
- At least 1 year experience with technical writing preferred
- Minimum 3 years Pharma experience preferred
- Proficient with Adobe PDF, Illustrator/In Design, Microsoft Office and advanced computer skills
- Continuous working knowledge of applicable FDA/ICH/DEA regulations
- Continuous working knowledge of applicable cGMP guidelines
N/A
Licenses
N/A
Other
N/A
- Physical demand and Work environment:
- Physical demands:
- Work environment:
Salary : $55,000 - $72,000
Associate Director, Regulatory Medical Writing
Johnson & Johnson -
Titusville, NJ
Associate Director - Global Regulatory Lead
BioSpace -
Plainsboro, NJ
Associate Director/Director Global Regulatory Affairs - CMC
Genmab A/S -
Princeton, NJ